Earlier this month, the FDA released programmatic guidance intended to clarify the current review practices for the Humanitarian Device Exemption (“HDE”) Program (“Guidance”) reflecting recent changes in the HDE Program resulting from statutory amendments made by the 21st Century Cures. The Guidance addresses frequently asked questions about FDA actions on HDE applications, post-approval requirements, and includes a filing checklist to clarify the required information for the FDA to consider whether an HDE application is ready for substantive review.
Unlike ...
On December 7, 2018, the U.S. Food and Drug Administration (“FDA”) published a proposed rule (“Proposed Rule”) that, if finalized, would clarify the de novo classification process for medical devices, including (1) the format and contents of a de novo request and (2) the criteria for accepting or denying a de novo request. FDA intends to “enhance regulatory clarity and predictability... [and] provide a regulatory framework that sets clear standards, expectations and processes for de novo classification” through this proposed rulemaking.[1]
FDA regulates medical ...
Blog Editors
Recent Updates
- CMS Tells States “No More” Medicaid Section 1115 Matching Funds for Designated State Health Programs (DSHP) and Designated State Investment Programs (DSIP)
- Podcast: Executive Actions Impact Federally Funded Research - What Institutions Should Do Now – Diagnosing Health Care
- A Closer Look at Proposed Changes to Medicare Advantage in the “No UPCODE Act”
- Green Commercial Leases
- Podcast: Criminal Health Care Fraud Enforcement - Projections for 2025 and Beyond – Diagnosing Health Care